Advances in the treatment of Alzheimer’s could not be achieved without the help of investigators. But the research wouldn’t be possible without the participation of important people: the patients.
Before any medical treatment can be approved by the U.S. Food and Drug Administration, it requires several research studies to prove that the treatment is safe and effective. That’s where clinical trials come in. Clinical trials, also called clinical studies, are carefully conducted research studies using human volunteers to answer specific questions about a treatment for a condition. The treatment might be a new vaccine, drug, medical device, or procedure.
The trials are done after research in laboratories shows promising results in animals. The goal is then to find out how the new therapy or procedure will work in people, and to determine its risks and its effectiveness. Clinical trials also look at methods of prevention, diagnosis, screening, and ways to improve quality of life.
Several different kinds of organizations are involved in clinical trials, including doctors, medical institutions, pharmaceutical companies, foundations, and government agencies. The trials are conducted in various settings, ranging from a small doctor’s office to a large university setting or hospital. All clinical trials are governed by an Institutional Review Board made up of an independent committee of physicians, community advocates, and others that oversees the ethics of the research, ensures diat the rights of the participants are protected, and reviews the research on a periodic basis.
As a person with Alzheimer’s, you might consider participating in a clinical trial of a treatment or procedure for the disease. By doing so, you might gain access to a medication that is not widely available. You may also enjoy medical care at leading health care facilities. Some people may feel they’ve exhausted all other options. For others, the altruism of contributing to science and medicine may be enough to convince them to join a clinical trial.
Before you can participate however, you have to make sure you qualify for the trial. Some people may be excluded because of age, gender, the stage of the disease, and other medical conditions. Some trials want candidates who have a certain condition. After meeting with the doctors and nurses involved in the trial, you will need to sign an informed consent document that says you understand the risks and benefits of participating.
Being part of a clinical trial does involve risks. Some participants might be given a placebo, or inactive treatment, which is used to gauge the treatment’s effectiveness. If you do receive the treatment, you may experience unpleasant, even life-threatening side effects. You will also have to endure more frequent visits to the testing site, treatments, and hospital stays than normal. And for all the time and energy you invest, you may also find that the treatment has no beneficial effect on your condition.
To Help You Decide
According to clinicaltrials.gov, a Web site of the National Institutes of Health, there are several things you should know before you decide to participate in a clinical trial:
• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
• What kinds of tests and treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with the medications I’m currently taking for the disease?
• How might this trial affect my life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow-up care is part of the study?
• How will I know if the treatment is working?
• Will I see the results of the trial?
• Who will be in charge of my care?
Before you make any final decision, talk to your physician, family members, and friends. Balance the positives with the negatives and gather information about specific trials.
It’s hard to predict when any of these research efforts will become a part of our medical care for Alzheimer’s—or whether some ever will. But scientists are forging ahead with efforts to understand this disease that just a century ago didn’t even have a name. The intensity of these efforts suggests that there is hope that one day we will gain control over this illness.